Inspections, Compliance, Enforcement, and Criminal Investigations

Nutri-Dyn Midwest, Inc. 1/15/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone:(612) 334-4100
FAX:(612) 334-4142

 

January 15, 2016
 
 
WARNING LETTER
 
 
Via UPS Overnight Delivery                                               
Refer to MIN 16 - 06
 
 
David S. Peterson
President and Co-owner
Nutri-Dyn Midwest, Inc.
5414 Highway 12
Maple Plain, Minnesota 55359
 
Dear Mr. Peterson:
 
On March 24, 25, 30, 31, April 1, and 10, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 5414 Highway 12, Maple Plain, Minnesota. Based on the inspection, a review of the product labeling you provided during the inspection, and our subsequent review of your website www.nutri-dyn.com, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
                                              
Unapproved New Drugs
 
This is to advise you that FDA reviewed your website at the Internet address www.nutri-dyn.com in July 2015 and determined that you take orders there for the products Cardioauxin™ BP, Zinc Lozenge, Oliver, Pau D’Arco, Petadolex, Chondro Jointaide, Dynagesic, SAMe-200, and Gugulipid. In addition, FDA reviewed your product labeling for your CaridoAuxin™ BP, Coenzyyme Q10, OmegaGenics™ Mega 10™, ArginCor™, NutrihCG, NutrihCG Reset, Nutri DMSA, Metal Detox, D3 5000, Cardioauxin™ and Red Yeast Extract Extra Strength products following an inspection at your facility at 5414 Highway 12, Maple Plain, Minnesota between March 24 and April 10, 2015. The claims on your website and other product labeling establish that the products are drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. 
 
Examples of some of the claims that provide evidence that your products are intended for use as drugs include: 
 
From the website www.nutri-dyn.com:
Cardioauxin™ BP (Nutri-Dyn brand) – 
  • “…[P]atent pending grape seed product from Polyphenolics that reduces blood pressure by relaxing the blood vessels.”
 
Zinc Lozenge (DNA Laboratories brand) –
  • “Natural Cold and Sore Throat Relief”
  • “A number of controlled trials have examined the effect of zinc lozenges on the common cold and documented that utilizing zinc lozenges reduces the duration of the common cold and are soothing to the throat.”
 
Oliver (Progressive Labs brand) –
  • “Anti-Yeast and Anti-Fungal”
  • “…[P]roven useful for combating a wide range of viral and bacterial infections.”
 
Pau D’Arco (DNA Laboratories brand) –
  • “Nutritional Support Against Bacterial, Viral, and Yeast Infections”
  • “…Pau D’Arco has anti-malarial, antibacterial, anti-fungal, anti-parasitic…activity.”
 
Petadolex (Weber & Weber USA brand) –
·        “Migraine Relief”
·        “…[A] powerful source of migraine relief. Petasites hybridus is described as…anti-inflammatory, and pain relieving effects.”
Chondro Jointaide (Nutri-Dyn brand) –
  • “Extra Strength Nutritional Support for Joint and Muscle Pain*”
 
Dynagesic (DNA Laboratories brand) –
  • “Natural Support for Pain and Inflammation…Dynagesic is an exclusive enzymatically prepared mixture of: Activated White Willow Bark Salicin (effective on rheumatic pain…Feverfew (helps relieve menstrual cramps, migraine headache, and overall systemic pain)…dl-Phenylalanine (increases the body’s natural pain relievers)”
 
SAMe-200 (Progressive Labs brand) –
  • “…[T]hese vitamins result in low concentrations of SAMe in the central nervous system (CNS). Low blood or CNS levels have been detected in people with cirrhosis of the liver, coronary heart disease, Alzheimer’s disease, and depression. SAMe has been effectively used as an antidepressant; it is beneficial for disorders of the joints and connective tissues, such as osteoarthritis and fibromyalgia…it may lower homocysteine levels, an amino acid associated with cardiovascular disease.”
 
Gugulipid, Standardized Extract 340 mg (Progressive Labs brand) –
  • “Gugulipid is the oleoresin of the Indian Herb Commiphora Mukul (or gum guggul).  This product is an ancient Ayurvedic medicine proven effective by modern research to…reduce elevated serum cholesterol with significant reductions in LDL…protect against cholesterol-induced atherosclerosis…reduce body weight in obese patients with elevated cholesterol levels…”
 
From the CardioAuxin product brochure:
CardioAuxin® BP, Coenzyyme Q10, OmegaGenics™ Mega 10™ and ArginCor™ –
  • “1 in 4 deaths in the United States is due to heart disease. That’s as many as 600,000 people annually. Heart disease remains the leading cause of death for both men and women. Coronary heart disease alone costs the United States $108.9 billion each year! Consider a plan for heart disease prevention.”
 
ArginCor™
  • “Medical food for Peripheral Artery Disease”
 
From the NutrihCG product brochure which promotes both the NutrihCG and the NutrihCG Reset product kits:
  • “…[D]ecrease chronic diseases such as cardiovascular disease, diabetes, and cancer…positively affects neurologic disorders…”
 
Note:  Per the catalog, the products in the NutrihCG kit include:
Detox Phase l and II - Balanced Detoxification Support
Thyroid – Glandular Thyroid Support Formula
Dynamic Fruits & Greens – Nutrient-Rich SuperFood Formula
 
The products in the NutrihCG Reset kit include:
Humanofort - Adrenal Support
Crave-Curb - Neurotransmitter Support
Ultimate Fat Burner-Metabolism Boost
Multi Caps - Vitamin and Mineral Support
 
From the Nutri-DMSA brochure:
  • “Nutri-DMSA product is intended to chelate heavy metal toxins such as mercury, lead, cadmium, arsenic, copper, bismuth, antimony, etc. ... DMSA is generally agreed upon by leading experts as the compound of choice for mercury detoxification.”
 
From the Metal Detox brochure:
·        “Metal Detox can remove toxic metals such as lead, mercury, aluminum, arsenic, cadmium, nickel, bismuth, tin, antimony and other metals.  This product can be used by itself or in conjunction with other oral chelating formulas…. EDTA has been an approved oral chelation compound since the 1950s with over 500 peer reviewed published studies. ...daily intake has been proven to be efficacious in the removal of lead, arsenic, cadmium and other heavy metals in acute and chronic poisoning. … In addition, garlic has been shown to reverse arteriosclerosis, reduce clotting tendencies, reduce LDL cholesterol, protect against organic toxins (i.e., red food dyes), and it has anti-microbial action against viruses…bacteria species.  Allicin [a liquid present in garlic] has recently been proven to eradicate the ‘superbug’ methicillin-resistant staphylococcus aureus (MRSA) that is responsible for 2000 deaths/year in the United Kingdom. … Malic acid is also an iron chelator…. Many Infections require the presence of available iron to maintain their active growth and reproduction.”

 
From the product Catalog:
Nutri-Dyn brand: D3 5000
·        “Helps in cancer prevention”
 
Cardioauxin™
·        “…[H]ave proven to be a very efficacious lipid-lowering, heart risk reduction formula.”
 
Red Yeast Extract Extra Strength
·        “…[S]trong effects on cholesterols/triglyceride lowering have been proven by short and long term clinical studies.”
 
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331 (d) and 355 ()]. FA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended uses.  “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended, Title 21, Code of Federal Regulations (21 CFR), 201.5. Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your products Pau D’Arco (DNA Laboratories brand), SAMe-200 (Progressive Labs brand), Gugulipids, Standardized Extract 340 mg (Progressive Labs brand), Metal Detox, D3 5000, CardioAuxin™ BP, Coenzyme Q10, OmegaGenics™ Mega 10™ and ArginCor™ are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Pau D’Arco (DNA Laboratories brand), SAMe-200 (Progressive Labs brand), Gugulipids, Standardized Extract 340 mg (Progressive Labs brand), Metal Detox, D3 5000, CardioAuxin™ BP, Coenzyme Q10, OmegaGenics™ Mega 10™, and ArginCor™ fail to bear adequate directions for their intended uses and are, therefore, misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
 
Nutri-DMSA product
 
DMSA, which is listed as an ingredient in your Nutri-DMSA product, is the active pharmaceutical ingredient (API) in the FDA-approved drug DMSA Kit for the Preparation of Technetium TC-99M Succimer for Injection (hereinafter “DMSA Kit”), approved on May 18, 1982, for the use as an aid in the scintigraphic evaluation of renal parenchymal disorders and (b)(4)®, approved on January 30, 1991, to treat lead poisoning in pediatric patients.  You market Nutri-DMSA as a dietary supplement.  However, under section 201(ff)(3)(B) of the Act [21 U.S.C. § 321(ff)(3)(B)], dietary supplements cannot contain an article that is approved as a new drug under section 505 of the Act unless that article was marketed as a dietary supplement or food prior to FDA approval of such drug.  To the best of our knowledge, DMSA was not marketed as a dietary supplement or food prior to FDA’s approval of DMSA Kit or (b)(4)®. Therefore, your product Nutri-DMSA is excluded from the definition of a dietary supplement under section 201(ff)(3)(B) of the Act.
 
Based on the claims, your product Nutri-DMSA is a drug under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of claims that establish the intended use of Nutri-DMSA include, but may not be limited to, the following:
 
     Nutri-DMSA product is intended to chelate heavy metal toxins such as mercury, lead, cadmium, arsenic, copper, bismuth, antimony, etc.”
 
     “DMSA has been investigated in a number of research studies in animals and humans as being effective in the reduction of toxic metals.”
 
     “DMSA is generally agreed upon by leading experts as the compound of choice for mercury detoxification.”
 
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
 
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended uses.  “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5).  Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
 
Your product Nutri-DMSA is offered for conditions not amenable to self-diagnosis and treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Nutri-DMSA fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
 
Homeopathic drug products
 
We also reviewed evidence which includes, but is not limited to, your website www.nutri-dyn.com for your drug products Allergy Drops, HCG Plus, and Flu Terminator.  According to the claims found on the product labeling of your products Allergy Drops, HCG Plus, and Flu Terminator, they are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended to diagnose, cure, mitigate, treat, or prevent disease, and/or articles (other than food) intended to affect the structure or any function of the body. 
 
Examples of claims that establish the intended use for these products include, but may not be limited to, the following:
 
Allergy Drops (claims on website www.nutri-dyn.com:)
 
·        “Homeopathic Combination for Allergy Relief”
·        “BeWell Allergy Drops modulates the symptoms of allergies:  Eyes: Itchy eyes, excessive lacrymation [sic], sensitive eyes, burning of the eyelids. Nose: watery discharge of the nose, itching nose, sneezing, hay fever, burning nose, burning mouth, burning throat also bladder and skin. Lungs: Cough, catarrh”
 
HCG Plus (claim on product label)
  •  “Helps normalize metabolism”
 
Flu Terminator (claims on website www.nutri-dyn.com:)
  • “Flu Terminator”
  • “Broad Spectrum Homeopathic Remedy for Influenza”
 
We recognize that Allergy Drops, HCG Plus, and Flu Terminator products are represented as being homeopathic drugs with active ingredients measured in homeopathic strengths.  The definition of “drug” in section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drugs are subject to the same regulatory requirements as other drugs; nothing in the Act exempts homeopathic drugs from any of the requirements related to adulteration, labeling, misbranding, or approval. We acknowledge that many homeopathic drugs are manufactured and distributed without FDA approval under enforcement policies set out in the Agency’s Compliance Policy Guide entitled “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 400.400)” (the CPG). As its title suggests, the CPG identifies specific conditions under which homeopathic drugs may ordinarily be marketed. Thus, in order to fall under the enforcement policies set forth in the CPG, a homeopathic product must meet the conditions set forth in the CPG.
 
As stated in the CPG, a homeopathic drug is defined as a drug labeled as homeopathic and that contains active ingredients listed in the HPUS, an addendum to it, or its supplements. The CPG also states that drug products containing homeopathic ingredients in combination with non-homeopathic active ingredients are not homeopathic drug products.
 
The following active ingredients were declared on the product labeling:
 
•   “Lung histamine 5C” in Allergy Drops;
 
•   “HCG 12X, 30X, 60X” in HCG Plus.
 
The active ingredients “Lung histamine” and “HCG” are not established homeopathic active ingredients in the HPUS or any of its addenda or supplements. As a result, “Lung histamine” and “HCG” are not homeopathic ingredients and Allergy Drops and HCG Plus are not considered homeopathic drugs under the CPG. Accordingly, the policies set forth in the CPG for the marketing of homeopathic drug products do not apply to these products.  Allergy Drops and HCG Plus are “new drugs” as defined in section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it.
 
HCG Plus and Flu Terminator are also misbranded under section 503(b)(4) of the Act [21 U.S.C. § 353(b)(4)] because their labels fail to bear the symbol “Rx only.”1  Section 503(b)(1) of the Act [21 U.S.C. § 353(b)(1)] identifies criteria for determining the prescription status of a product. HCG plus and Flu Terminator are "prescription drugs" as defined in section 503(b)(1)(A) of the [21 U.S.C. § 353(b)(1)(A)] because, in light of their toxicity or other potentiality for harmful effect, or the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer such drug.
 
The label for HCG Plus states that this product contains hypothalamus, pituitary, and thyroid, and that it is intended to “normalize metabolism,” suggesting there is a potential underlying condition affecting metabolism, which would require diagnosis and treatment by a health care provider. Furthermore, the labeling for Flu Terminator suggests that this product is intended to treat or cure influenza, a disease that requires diagnosis and treatment by a health care provider.
 
As described in the CPG, homeopathic drugs must comply with the labeling provisions of section 503(b) of the Act. The CPG states that “[h]omeopathic products intended solely for self-limiting disease conditions amenable to self-diagnosis (of symptoms) and treatment may be marketed OTC.  Homeopathic products offered for conditions not amenable to OTC use must be marketed as prescription products.”
 
The introduction or delivery for introduction of misbranded drugs into interstate commerce violates section 301(a) of the Act [21 U.S.C. § 331(a)].
 
We acknowledge that at the end of our inspection of your facility, you stated that your firm would no longer distribute HCG Plus and Nutri-DMSA products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
 
Additionally, firms that are engaged in the manufacture, preparation, propagation, compounding, or processing of drugs in the United States or that are offered for import into the United States must register their establishment with the FDA and submit an annual establishment registration in a period between October 1st and December 31st as described under section 510 of the Act [21 U.S.C. § 360] and 21 CFR Part 207.  Our records show your firm does not have a current drug establishment registration on file with FDA and not all drug products are listed with FDA as of December 2, 2015. It is your responsibility to ensure that your establishment registration and drug listing with FDA is up-to-date and accurate. FDA regulations in 21 CFR Part 207 specify the requirements for registering and listing.
 
 
Dietary Supplement CGMP Violations
 
Even if your CardioAuxin™ BP Product did not have therapeutic claims which make it a drug, that product and all of the dietary supplement products that you manufacture would still be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, 21 CFR Part 111.
 
Specifically, during our inspection our investigators observed the following violations, which were noted on form FDA-483, Inspectional Observations, issued to you on April 10, 2015. The significant violations documented during the inspection include, but are not limited to, the following:
 
1. You failed to establish finished product specifications for each dietary supplement product that you manufacture for identity, purity, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(e). Further, for those specifications you have established, you failed to provide adequate documentation to determine that compliance with the specifications you selected for strength and composition will ensure the finished batch of dietary supplement meets your specifications, as required by 21 CFR 111.75(c)(3).
 
Your August 28, 2015, response failed to demonstrate that you have established specifications for both identity and purity of each of your finished dietary supplement products.  Once you have established the required specifications, you must verify that your finished dietary supplements meet those product specifications for identity, purity, strength, composition, and for limits on those types of contamination that may adulterate or that may lead to adulteration of the finished batch of supplements, as required by 21 CFR 111.75(c). The methods shown in the response do not clearly show how you will verify the specifications for identity, purity and limits of contamination that may adulterate or may lead to adulteration of your products. For example, you have a quantitative method for the “Active Ingredients,” but while such methods may indicate the strength of the dietary ingredients, they do not adequately provide for identification of purity of the ingredient. Further, the listing for microbiological specification appears to offer two matrices:  with or without rice powder.  This listing does not appear to be specific for the product but is, instead, a generic listing. As such, it does not take the unique character of the actual product into consideration as to the contaminants which may adulterate or lead to the adulteration of the finished product. 
 
2.    You failed to investigate product complaints as required by 21 CFR 111.560(a)(2). For example, you did not investigate three customer product complaints regarding adverse events that included flushing, hives, heart palpitation, and GI distress, resulting in two individuals going to the emergency room for treatment. Further, you did not investigate one complaint regarding an incorrect number of capsules per bottle. 
 
Your written response of May 1, 2015, stated that a detailed log of all customer complaints will be maintained and reviewed by qualified individuals, that all complaints will be investigated, and that all complaints will be resolved. However, your response did not include documentation of the written procedures for fulfilling the requirements of 21 CFR Part 111, which are required under 21 CFR 111.570(b)(1).
 
Dietary Supplement Misbranding
 
Your Ultimate Male, lot 131087, is misbranded under section 403(a)(1) of the Act [21 U.S.C. § 343(a)(1)] in that the labeling is false and misleading because the amount of Grapeseed Extract and L-Argenine present in the product is significantly less than the amount declared. The label for Ultimate Male states that Grapeseed Extract will be at 500 mg/serving and the L-Arginine will be at 1700 mg/serving. Testing provided by your third party contract laboratory revealed Grapeseed Extract at 185.00 mg/serving and L-Arginine at 973.60 mg/serving.
 
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.  You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
We note that to the extent you contract with a firm (as a contract manufacturer) to manufacture product for your firm, you failed to keep documentation to ensure that in all phases of the production, your products are in compliance with dietary supplement CGMP requirements. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.  [See United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”), and United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)]. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. § 342(g) and 331(a)]. Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). 
 
If you receive product from a contract manufacturer, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement [21 CFR 111.127(h) and 111.140(b)(2)].  In addition, you must establish and follow written procedures for the responsibilities of the quality control operations (21 CFR 111.103). 
 
Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
 
Within 15 working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
 
Your response should be addressed to Compliance Officer Dianna C. Sonnenburg at the address indicated on the letterhead. 
 
Sincerely,
/s/ 
Michael Dutcher, DVM
Director
Minneapolis District

 

1 The CPG states that “prescription homeopathic drug products must bear the prescription legend “Caution: Federal law prohibits dispensing without prescription, in conformance with Section 503(b)(1) of the Act.”  This guidance was issued by the agency in 1988.  In 1997, Congress enacted the Food and Drug Administration Modernization Act (FDAMA); section 126 of FDAMA amended section 503(b)(4) of the Act to require that the label of a prescription drug must bear, at a minimum, the symbol “Rx only.”

 

 
 
 
 
 

 

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